Low-energy diet to improve heart function in patients with heart failure
A Multi-Ethnic, Multi-centre raNdomised, Controlled Trial of a Low-energy Diet for Improving Functional Status in Heart Failure With PRESERVED Ejection Fraction (AMEND-preserved)
This study is testing if a low-energy meal replacement plan can help people with heart failure feel better and improve their heart function over 12 weeks.
Quick facts
| Phase | Phase2; Phase3 |
|---|---|
| Study type | Interventional |
| Enrollment | 63 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Leicester Academic / other |
| Locations | 3 sites (Leicester, Leicestershire and 2 other locations) |
| Trial ID | NCT05887271 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effects of a low-energy meal replacement plan on patients with heart failure with preserved ejection fraction (HFpEF), a condition often associated with obesity and type 2 diabetes. The study will randomly assign 102 adults to either a 12-week diet intervention or a control group receiving health advice for weight loss. The primary focus is to assess improvements in heart function, exercise capacity, and overall quality of life among participants. The trial aims to gather insights from a diverse cohort across three sites in the UK, leveraging previous pilot data that indicated potential benefits of weight loss in similar populations.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with a clinical diagnosis of HFpEF and obesity.
Not a fit: Patients with severe comorbidities or those unable to follow a low-energy diet may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly enhance the quality of life and functional status for patients suffering from HFpEF.
How similar studies have performed: Previous studies have shown promising results with similar dietary interventions in related populations, indicating potential for success in this trial.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Established clinical diagnosis of heart failure with preserved ejection fraction HFpEF (EF\>45%) made by a cardiologist or a primary care physician with heart failure expertise, or a heart failure nurse 2. Clinically stable for ≥ 3 months (no admissions to hospital) 3. Obesity (BMI ≥30kg/m2 if white European or ≥27kg/m2 if Asian, Middle Eastern or Black ethnicity) 4. Age ≥18 Exclusion Criteria: 1. Inability to walk/undertake 6-minute walk test 2. Inability to follow a low-energy MRP 3. HFpEF due to infiltrative cardiomyopathy (cardiac amyloidosis or sarcoidosis), genetic hypertrophic cardiomyopathy, restrictive cardiomyopathy/pericardial disease or congenital heart disease. 4. Recovered EF (previous EF \< 40%) unless reduced EF was in context of tachycardia induced cardiomyopathy (eg AF/Aflutter). 5. Known heritable, idiopathic or drug-induced pulmonary arterial hypertension 6. Severe chronic obstructive pulmonary disease (FEV1\< 1.0L) 7. Severe primary valvular heart disease 8. Anaemia (Hb\<100g/L) 9. Severe renal disease (eGFR \< 30 ml/min/1.73 m2) 10. Weight loss \> 5kg in preceding 3 months. 11. Symptomatic gallstones (including biliary colic) or cholecystitis within last 3 months 12. Active substance abuse (drugs or alcohol) 13. History of bariatric surgery in the last 3 years 14. Active illness likely to cause change in weight 15. Women who are pregnant or are considering pregnancy 16. People currently participating in another clinical research trial that is likely to affect diet or weight change. 17. History of a severe mental illness including an eating disorder 17\. Individuals with a diagnosis of Type 1 diabetes mellitus.
Where this trial is running
Leicester, Leicestershire and 2 other locations
- University of Leicester, Glenfield Hospital, Groby Road — Leicester, Leicestershire, United Kingdom (Recruiting)
- University of Manchester, Wythenshawe Hospital, Southmoor Road — Manchester, United Kingdom (Recruiting)
- University of Oxford, John Radcliffe Hospital, Headley Way — Oxford, United Kingdom (Recruiting)
Study contacts
- Principal investigator: Gerry P McCann, MD — University of Leicester
- Study coordinator: Sarah L Ayton, MBBS
- Email: sa768@leicester.ac.uk
- Phone: +44 (0)116 258 3038
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.